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Death Caused by Januvia & Byetta

Byetta and Januvia have gained widespread popularity for the treatment of type 2 diabetes, despite concerns about the risk for acute pancreatitis, pancreatic cancer and death. Manufactured by Amylin Pharmaceuticals Inc. (Byetta) and Merck (Januvia), both are incretin mimetics – a class of drugs linked with the onset of life-threatening complications.

The bulk of litigation arising from Januvia-related deaths contends that the glucagon-like peptide 1 (GLP-1) therapy caused the decedent to develop pancreatic inflammation and cancer, ultimately causing their untimely demise. Allegations raised in wrongful death lawsuits brought against Byetta and Januvia drug makers may be bolstered by research published in the journal, Gastroenterology.

During their study, researchers reviewed FDA adverse events logged between 2004 -2009 for reports of pancreatitis, pancreatic cancer and thyroid cancer in association with the use of sitagliptin (Januvia) or exenatide (Byetta). Scientists discovered a “6-fold increase in the odds ratio for reported cases of pancreatitis in patients receiving sitagliptin or exenatide compared with the control diabetes therapies.”

The American Cancer Society cautions that pancreatitis is a known precursor for pancreatic cancer, which has an extremely dire prognosis for patients. The average survival rate for those with advanced stages of the disease is between six and ten months.

FDA warns of incretin mimetics and pancreatic risks

In 2009, the U.S. Food and Drug Administration (FDA) alerted consumers about post-marketing reports concerning acute pancreatitis, including fatal and nonfatal cases tied to Januvia and Byetta. The agency’s analysis found that 21 percent of the 88 reported pancreatitis cases occurred within one month of beginning treatment with sitagliptin or sitagliptin/metformin.

Health regulators say that individuals should stop treatment with the incretin mimetics should symptoms of acute pancreatitis surface, such as abdominal pain, loss of appetite or nausea, as they could portend much more serious complications.

Januvia and Byetta function by mimicking the incretin hormones naturally produced by healthy individuals, which stimulate the release of insulin. These diabetes drugs have proven incredibly lucrative for manufacturers, earning Merck more than $2.6 billion in 2013.

Despite the drugs’ blockbuster success, the FDA states that it will continue to analyze all available data to better determine incretin mimetic safety issues. While at least two fatal pancreatic cases have been identified in association with incretin mimetics, the exact numbers of Januvia and Byetta deaths are not known at this point.

JAMA study highlights potential dangers of Januvia, Byetta

Research published in the February 2013 online edition of JAMA Internal Medicine found that patients who were hospitalized with acute pancreatitis were twice as likely to be taking Januvia or Byetta compared to type 2 diabetics who were not diagnosed with pancreatitis.

Jaundice, abdominal pain, diminished appetite, fever and vomiting are early signs of acute pancreatitis, a condition that develops suddenly and may predispose patients to pre-cancerous cellular changes.

In last year’s drug safety communication, the FDA stated it was “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.”

Patients who are unfortunate enough to develop pancreatic cancer from incretin mimetic therapy with Januvia or Byetta have a grim survival rate. Often known as the silent killer, pancreatic cancer seldom has early symptoms, making it difficult to diagnose until the cancer has spread significantly.

Byetta and Januvia death toll prompts legal action

While incretin mimetics have helped millions of Americans combat the effects of Type 2 diabetes, reports of pancreatitis and pancreatic cancer in patients exposed to Byetta and Januvia continue to escalate.

FDA adverse event reports show that by the end of 2012, 33 patients taking Januvia had died from pancreatic cancer, of which there were nearly 140 reported cases. And post-marketing reports on Byetta cancer risks are even more ominous. U.S. health regulators have received some 1,304 reports of acute pancreatitis attributed to Byetta and more than 300 pancreatic cancer cases.

Dozens of Americans who lost a loved one to pancreatic cancer following incretin mimetic treatment have gone on to file a wrongful death claim, in an attempt to hold Januvia and Byetta drug makers liable for misrepresenting the safety of their products, while failing to warn of adverse side effects.

Monetary damages sought by plaintiffs include loss of wages, medical monitoring, exemplary and punitive damages, pain and suffering, mental anguish and legal fees.

In one recent Januvia death lawsuit filed in California federal court, the claimant argues that the defendants, “willfully, wantonly, and with malice withheld the knowledge of increased risk of pancreatic cancer in users of Byetta and Januvia to prevent any chances of their product’s registration being delayed or rejected by FDA.”

Causes of action commonly listed in Januvia & Byetta complaints include:

  • Negligent misrepresentation
  • Breach of implied and express warranties
  • Strict product liability – failure to warn
  • Fraud by concealment
  • Wrongful death

Litigation centralized on federal and state level

To more efficiently process the growing litigation regarding Byetta and Januvia injuries and deaths, all claims brought in federal court have been centralized in the Southern District of California under District Judge Anthony J. Battaglia. The incretin mimetics products liability multidistrict litigation No. 2452 has amassed more than 275 cases, all containing similar allegations and issues of fact.

In addition to federal MDL, claims filed in state court have been coordinated for pretrial proceedings before Judge William F. Highberger in Los Angeles Superior Court. Litigants allege that treatment with Victoza, Janumet, Januvia and Byetta caused pancreatic cancer and/or the untimely death of a loved one.

  1. FDA, FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes,
  2. eHealthme, Review: could Januvia cause Sudden death?
  3., Selected Risk Information About JANUVIA,
  4. NBC News, More deaths linked to diabetes drug Byetta,
  5. JAMA, Glucagonlike Peptide 1–Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes Mellitus,
  6. Medscape, Pancreatic Cancer Reports Increase With 2 Diabetes Drugs,
  7. Gastroenterology, Pancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based Therapies,